Integrity test coupling

Abstract

Included in the present disclosure is a device, including a fitting having a first opening, a second opening, and a flowpath therebetween. In some embodiments, the device includes a filter disposed within the flowpath, the filter configured to remove impurities from a fluid.

Description

INTEGRITY TEST COUPLINGCROSS-REFERNCE

[0001] The entire contents of the following application are incorporated by reference herein: U.S. Provisional Patent Application No. 63 / 560,653; filed March 2, 2024; and entitled CLOSED PROCESS FOR FILLING.Field of Technology

[0002] The present disclosure relates to verification of the integrity of a system. Specifically, the present disclosure relates to the use of a fitting for integrity testing via pressurization.Background

[0003] Medical treatments, biological sampling, hazardous materials, and high value solutions often require transference from one system to another while maintaining protection from environmental contaminants and / or protection of personnel from the solution. Assurance that the conveyance and receiving system are integral may be accomplished through means of pressure decay, vacuum decay, or indicator gas detection. When tested in such manner, an inlet / outlet is needed which ensures that the entering / exiting liquids and / or gasses do not convey contaminants into the system or materials from within out of the system. In some embodiments this is by appending to the initial design of system, a set of tees, extension of conduit / channel, and filters(s).

[0004] Some assemblies, including flowpaths, need to meet cleanliness and sterile requirements, especially those in the medical field, where contamination could prove life-threatening. Typically, this is achieved through assembling the assemblies in an environment suitable for ensuring the internal surfaces meet these requirements. Often, they are also post-assembly processed further to attain the target internal environment (e.g., through flushing with purified water, drying, sterilizing via gamma radiation, using an e-beam, using ultraviolet light, steaming, drying, etc.).SUMMARY

[0005] Included in the present disclosure is a device, including a fitting having a first opening, a second opening, and a flowpath therebetween. In some embodiments, the device includes a filter disposed within the flowpath, the filter configured to remove impurities from a fluid.

[0006] According to some embodiments, the filter includes i) a single-layer hydrophobic filter, ii) a hydrophobic large pore fabric, iii) a positively charged filter material, iv) a negatively charged filter material, v) a multi-charged filter, vi) a sterilizing grade filter, or vii) combinations thereof.

[0007] The filter may be completely contained within the fitting. In some embodiments, the filter includes a maximum dimension from about 0.5 millimeters (mm)and about 500 millimeters (mm). According to some embodiments, the filter includes a maximum thickness from about 0.5 mm and about 100 mm. The fitting may include i) a threaded fitting, ii) a hose barb, iii) a luer, iv) a sanitary connection, v) a quick connect, vi) or combinations thereof, and wherein the filter is embedded within the fitting.

[0008] In some embodiments, the device further includes a valve disposed within the flowpath, the valve configured to regulate a flow of the fluid therethrough. According to some embodiments, the valve includes a stopcock. The valve may include a three-way stopcock.

[0009] In some embodiments, the fitting is a T-fitting. According to some embodiments, the fitting includes a maximum inner dimension from about 0.1 mm and about 100 mm. The fluid may include a gas.

[0010] Also included in the present disclosure is a system, including a device as described in the preceding paragraphs. In some embodiments, the system includes an integrity test instrument fluidly coupled with the device.

[0011] According to some embodiments, the integrity test instrument includes a tubing that fluidly couples the integrity test instrument to the device. The tubing may define a gas flowpath. In some embodiments, the tubing fluidly couples the integrity test instrument to the first opening of the fitting. According to some embodiments, the integrity test instrument includes i) a gas regulator, ii) a gas manifold, iii) an integrity test regulator, iv) a gas supply valve, v) a pressure sensor, vi) a flow meter, vii) a computer, or viii) combinations thereof.

[0012] The system may further include a securing clamp configured to secure the tubing to the fitting. In some embodiments, the device is configured to fluidly couple to an closed system.According to some embodiments, the tubing is a first tubing, and the device is configured to couple to the closed system via a second tubing. The second tubing may define a test flowpath.

[0013] In some embodiments, the second tubing is configured to fluidly couple the closed system to the device via the second opening. According to some embodiments, the securing clamp is a first securing clamp, and the system further includes a second securing clamp configured to secure the second tubing to the fitting. The system may further include a pinch clamp located about the second tubing and configured to i) open, ii) restrict, iii) block, or iv) or any combination thereof the test flowpath.

[0014] In some embodiments, the closed system is a first closed system, and the device is further configured to fluidly couple to a second closed system. According to some embodiments, the device is configured to fluidly couple to the second closed system via a third tubing. The test flowpath may be a first test flowpath, and the third tubing may define a second test flowpath.

[0015] In some embodiments, the device includes a third opening, and the third tubing is configured to fluidly couple the second closed system to the device via the third opening. According to some embodiments, the system further includes a third securing clamp configured to secure the third tubing to the fitting.

[0016] The pinch clamp may be a first pinch clamp, and the system may further include a second pinch clamp located about the third tubing and configured to i) open, ii) restrict, iii) block, or iv) or any combination thereof the second test flowpath. In some embodiments, the filter and / or the device is configured to maintain a sterility of i) the first closed system, ii) the second closed system, iii) the flowpath, iv) the first test flowpath, v) the second test flowpath, or vi) combinations thereof.BRIEF DESCRIPTION OF DRAWINGS

[0017] These and other features, aspects, and advantages are described below with reference to the drawings, which are intended to illustrate, but not to limit, the invention. In the drawings, like characters denote corresponding features consistently throughout similar embodiments.

[0018] FIGS. 1, 2A, 2B, 3A, 3B, 4A, 4B, 5A, and 5B illustrate diagrammatic views of various systems including fittings having an integral filter, according to some embodiments.

[0019] FIG. 6 illustrates a diagrammatic view of an integrity testing machine, according to some embodiments.

[0020] FIG. 7 illustrates a flowchart depicting the overview of the process of integrity testing a flowpath of a system, according to some embodiments.

[0021] FIG. 8 illustrates a continuation of the flowchart of FIG. 7 depicting the overview of the process of integrity testing the flowpath of the system, according to some embodiments.

[0022] FIG. 9 illustrates a flowchart depicting a method of testing the integrity of the filling system, according to some embodiments.

[0023] FIG. 10 illustrates a flowchart depicting a method of performing helium testing, according to some embodiments.

[0024] FIG. 11 illustrates a flowchart depicting a method of performing pressure decay testing, according to some embodiments.DETAILED DESCRIPTION OF THE INVENTION

[0025] It may be desirable to perform integrity testing of a system purported to have isolation from the environment. A means may be necessary for connecting the integrity tester to the system to be tested without compromising the environmental isolation.

[0026] Further, it may be desired to connect two systems without exposure to the environment using an aseptic connection. After connecting the two systems, it may be desired to perform additional integrity testing of the aseptic connection to ensure that it is intact. A means may be necessary for connecting the integrity tester to the aseptic connection so that it may be tested without compromising its environmental isolation.

[0027] Current solutions to the above integrity testing needs have multiple drawbacks, which the present disclosure seeks to remedy. Many current solutions include numerous connection points. Each connection may be a potential leak and / or failure point.

[0028] Additionally, many current solutions include higher assembly costs. When an integrity testing solution is incorporated into a larger system, each individual component may need to be retrieved, and each individual connection may need to be made manually. As such, the number of connections may have an impact on operator / technician time, increasing the expense to assemble the device.

[0029] Furthermore, many current solutions include higher component costs. Filter material may generally be more expensive than other materials needed for an integrity test setup. Many current solutions use a large amount of filter material, increasing overhead costs.

[0030] Moreover, many current solutions are bulky, and / or complicated. Many current solutions for systems that require integrity testing may be complex in construction, being made up of multiple tubing lengths, branches, fitments, and connections. The bulkiness of the integrity test branch system may be an additive complexity and a hassle to manage. As systems become more complex, they may lead to operator confusion and errors in operation.

[0031] An additional concern in current solutions is non-microbial contamination. Many current solutions include filters that are single-layer hydrophobic (i.e., low charge / non-polar). These filters may be well suited for the removal of particles based on size. However, there may be contaminants that are a smaller size than these sterilizing grade filters (e.g., viruses, prions, protein fragments, nucleic acids, oils, solvents, etc.) and may contaminate the system if they are within the pressure test gas. As such, it may be desirable to enhance the protection of the pressure test gas barrier filter with additional other types of barriers. However, for current solutions, including multiple filters stacked to mitigate against these other contaminants may be cost prohibitive and exacerbate the number of connections, higher assembly costs, higher cumulative component costs, and bulkiness and complication, as listed above.

[0032] The current disclosure seeks to remedy these deficiencies by integrating one or more filters into the integrity test connector itself. Reducing the number of connections may, in turn, reduce the risk of leak and / or failure points, as fewer connections are needed. The reduced connections of the current disclosure may also reduce the time required for an operator / technician to assemble the system, resulting in a decrease in overall cost.

[0033] The amount of filter material needed for a filter integrated into the connector may be less, thereby reducing the overall cost needs for raw materials. Additionally, an integral test branch for the integrity test fitting minimizes the protrusion of the integrity test line, which may cause greater ease of use and less potential for confusion.

[0034] Finally, the present disclosure may include multiple layers of material within the same housing and compact connector in order to separate potential contaminants. The use of multiple layers may improve the contamination protection of the current disclosure over existing methods while decreasing the cost and maintaining a lower level of complexity and connections.

[0035] Examples of additional layers include a hydrophobic large pore fabric, which may provide a low surface area liquid contact portion that prevents process solutions from passing to subsequent layers of the filter and eliminates the need for a shutoff valve. A positively charged filter materialmay be used to bind to negatively charged potential contaminants (e.g., virus particles such as adenovirus and lentivirus). A negatively charged fdter material may be used to bind positively charged potential contaminants. A multi-charged fdter (e.g., activated carbon) may be used to bind potential polar contaminants of many sources. A sterilizing grade fdter(s) may be used as an outermost barrier of the integrity test in order to catch all large potential contaminants.

[0036] As used herein, “tubing” refers to any mechanism including a conduit for permitting fluid to flow therethrough. This includes but is not limited to “piping,” “hosing,” etc.

[0037] FIG. 1 illustrates a diagrammatic view of a system including a fitting 50 having an integral filter 60. As described herein, the fitting 50 may include one or more openings that define a flowpath therebetween. The filter 60 may be disposed along the flowpath, covering at least a portion of a cross-section of the flowpath. As shown in FIG. 1, the fitting may be configured to be fluidly coupled to one or more systems or assemblies, for example, including an upper system 10 and a lower system 20 connected to one another through piping means, such as tubing. In some embodiments, the lower system 20 is enclosed within a housing which also contains an integrity test instrument 30. The system as a whole may include the fitting and the integrity test instrument 30. The integrity test instrument 30 may include a compressor to provide gas, via the gas line 40, to each of the upper system 10 and the lower system 20 in order to check the integrity of each system as well as the connections leading to each.

[0038] The gas line 40 (which may be through a piping or tubing) extends from the integrity test instrument 30 to a fitting 50, here illustrated as a T-fitting. The fitting 50 may include a filter 60 integrated into the fitting 50 in order to save on material costs, space, and complexity, as detailed above. Additionally, the filter 60 may be made up of multiple filters, and / or any combination of filters, as described above.

[0039] Also shown in FIG. 1 is an upper system valve 70 along the piping leading from the fitting 50 to the upper system 10, as well as a lower system valve 80 along the piping leading from the fitting 50 to the lower system 20. In some embodiments, the integrity of the upper system 10 and its connections and the integrity of the lower system 20 and its connections may be checked separately from one another. For example, by turning the upper system valve 70 to an “on” position (e.g., opening the valve) and the lower system valve 80 to an “off’ position (e.g., closing the valve), gas being supplied by the integrity test instrument 30 through the gas line 40 and into the fitting 50 would be unable to reach the lower system 20, thereby only testing the integrity of the uppersystem 10. Likewise, by turning the upper system valve to an “off’ position and the lower system valve to an “on” position, gas being supplied by the integrity test instrument 30 through the gas line 40 and into the fitting 50 would be unable to reach the upper system 10, thereby only testing the integrity of the lower system 20.

[0040] Additionally, by turning both the upper system valve 70 and the lower system valve 80 to an “on” position, the integrity of both the upper system 10 and the lower system 20 may be checked at the same time. Finally, by turning both the upper system valve 70 and the lower system valve 80 to an “off’ position, the upper system 10 and the lower system 20 may be isolated from the integrity test instrument entirely, which may be useful for checking the integrity of the fitting 50 or gas line 40 themselves.

[0041] In some embodiments, a separate tubing may extend between the fitting 50 and one or both of the upper system and lower system valves 70 and 80. In such cases, each separate tubing (e.g., between fitting 50 and valve 70, and / or fitting 50 and valve 80) may need to be tested. Accordingly, a portion along the respective separate tubing or the tubing beyond the respective valves 70 and 80 (going towards the respective system 10 and 20) may be clamped so as to allow for testing of such separating tubing(s). Additionally or alternatively, each valve 70 and 80 may also be closed to allow for testing of the separate tubing(s).

[0042] FIG. 2A illustrates a diagrammatic view of a system including a fitting 208 having an integral filter, according to some embodiments. In some embodiments, the fitting 208 is a hose barb with embedded filter layers. As illustrated in FIG. 2A, the system includes an integrity test instrument 202 along with the fitting 208. The system (e.g., fitting 208 and integrity test instrument 202) may be fluidly coupled to a closed or substantially closed system 204. The gas line 40 (which may be via a tubing or piping) may be coupled with a first opening of the fitting 208, and fluidly coupled with a flowpath 212 within the fitting 208, which in turn may be fluidly coupled to the closed system 204. The fitting 208 is illustrated within the tubing 206 and coupled to the closed system 204, with the tubing secured to the fitting 208 through a securing clamp 210.

[0043] The fitting 208 may be an independent port connector containing the filter, and be directly bonded to the closed system 204. For example, the independent port connector may be a molded part on one of a bag, a sensor, a reducer, a housing, a sanitary connection, a hollow fiber housing, a bottle, a bottle cap, a chromatography housing, or a valve.

[0044] FIG. 2B illustrates a diagrammatic view of the system of FIG. 2A, stated in additional or alternate terms. In some embodiments, the fitting 208 (shown located within the dashed lines) includes a first opening 214 and a second opening 216. The fitting 208 may include a flowpath extending from the first opening 214 to the second opening 216. According to some embodiments, the gas line 40 is defined as a gas flowpath 212, and the gas flowpath 212 may permit the integrity test instrument 202 to fluidly couple to the flowpath within the fitting 208. To reiterate from FIG. 2A above, the filter may be located fully within the flowpath of the fitting 208, and not within the gas flowpath 212. The second opening 216 may permit the gas to flow from the flowpath of the fitting 208 into the closed system 204.

[0045] FIG. 3A illustrates a diagrammatic view of a system including a fitting 302 having an integral filter 304, according to some embodiments. In some embodiments, the fitting 302 is a t- fitting, or “Tee” with embedded filter 304 elements. As illustrated in FIG. 3A, the system includes an integrity test instrument 202 connected to a first closed system 204a and a second closed system 204b by way of a gas line 40 and / or tubing 206. The gas line 40 may run through tubing 206, which in turn may be coupled to the first closed system 204a and the second closed system 204b. The fitting 302 is illustrated within the tubing 206 and coupled to each of the first closed system 204a and the second closed system 204b, with the tubing secured to the fitting 302 by way of securing clamps 210 located between the filter 304 and the first closed system 204a, the filter 60 and the second closed system 204b, and along the portion of the fitting 302 coupled to the integrity test instrument 202 through securing clamps 210. An aseptic connection 308 may be present along the pathway between the fitting 302 and the first closed system 204a.

[0046] Between the first closed system 204a and the fitting 302 (or aseptic connection 308, if present), and between the fitting 302 and the second closed system 204b, pinch clamps 306 are shown. In some embodiments, the integrity of the first closed system 204a and its connections leading to the securing clamp 210 located between the fitting 302 and the first closed system 204a, as well as the integrity of the second closed system 204b and its connections leading to the securing clamp 210 located between the fitting 302 and the second closed system 204b may be checked separately from one another.

[0047] For example, by releasing the pinch clamp 306 located closest to the first closed system 204a and closing the pinch clamp 306 closest to the second closed system 204b, gas being supplied by the integrity test instrument 202 through the gas line 40 and into the fitting 302 would be unableto reach the second closed system 204b, thereby only testing the integrity of the first closed system 204a and its associated components. Likewise, by closing the pinch clamp 306 closest to the first closed system 204a and releasing the pinch clamp 306 closest to the second closed system 204b, gas being supplied by the integrity test instrument 202 through the gas line 40 and into the fitting 50 would be unable to reach the first closed system 204a, thereby only testing the integrity of the second closed system 204b and is associated components.

[0048] Additionally, by releasing both pinch clamps 306, the integrity of both the first closed system 204a, the second closed system 204b, and their associated components may be checked at the same time. Finally, by closing both pinch clamps 306, the first closed system 204a and the second closed system 204b may be isolated from the integrity test instrument 202, which may be useful for checking the integrity of the fitting 302, the gas line 40, and aseptic connection 308.

[0049] FIG. 3B illustrates a diagrammatic view of the system of FIG. 3 A, stated in additional or alternate terms. In some embodiments, the fitting 302 (shown located within the dashed lines) includes a first opening 312a, a second opening 312b, and a third opening 312c. The fitting may include a flowpath extending between the first opening 312a, the second opening 312b, and / or the third opening 312c. According to some embodiments, the gas line is defined as a gas flowpath 212, and the gas flowpath 212 may permit the integrity test instrument 202 to fluidly couple to the flowpath within the fitting 302.

[0050] The tubing 206 of FIG. 3 A may be separable components of tubing fluidly coupled with the fitting 302. For example, components of the tubing may be held in place on or about the fitting 302 by the aforementioned securing clamps 210. Specifically, a first tubing 206a may be used to fluidly couple the integrity test instrument 202 to the fitting 302, the first tubing 206a defining the gas flowpath 212 therein, a second tubing 206b may be used to fluidly couple the first closed system 204a to the fitting 302, the second tubing defining the first test flowpath 310a, and a third tubing 206c may be used to fluidly couple the second closed system 204b to the fitting 302, the third tubing defining the second test flowpath 310b therein.

[0051] The second opening 312b may permit the gas (e.g., from the integrity test instrument 202) to flow from the flowpath of the fitting 302 into the first closed system 204a by way of the first test flowpath 310a, and the third opening 312c may permit the gas to flow from the flowpath of the fitting 302 into the second closed system 204a by way of the second test flowpath 310b, thereby permitting integrity testing on the first closed system 204a, the second closed system 204b, thesecond tubing 206b, the third tubing 206c, the first test flowpath 310a, and / or the second test flowpath 310b.

[0052] To reiterate from FIG. 3A above, the filter may be integral to the fitting 302, meaning that it is located entirely within the flowpath of the fitting 302, and not within the gas flowpath 212, or either of the first test flowpath 310a or the second test flowpath 310b.

[0053] FIG. 4A illustrates a diagrammatic view of a system including a fitting 402 having an integral filter 304, according to some embodiments. The gas line 40, integrity test instrument 202, first closed system 204a, second closed system 204b, tubing 206, securing clamps 210, filter 304, pinch clamps 306, and aseptic connection 308 as shown in FIG. 4A may operate in the same manner as described above with respect to FIG. 3A.

[0054] The fitting 402 may be a T-fitting, or “Tee,” with an embedded stopcock and filter 304. The stopcock may permit the fitting 402 to isolate the flowpath between the first closed system 204a and the second closed system 204b from the integrity test instrument 202. This may permit closing off of the integrity test instrument 202 from the system as a whole when it is not in use. This configuration may have the benefit of enabling the first closed system 204a, the second closed system 204b, and their connections to maintain a positive pressure to the atmosphere and / or prevent process solutions from coming into contact with the embedded filter 304.

[0055] FIG. 4B illustrates a diagrammatic view of the system of FIG. 4A, stated in additional or alternate terms. As shown in FIG. 4B, the system may include an integrity test instrument 202 fluidly coupled to a fitting 402 via a first tubing 206a defining a gas flowpath 212 therein. The system may further include a first closed system 204a fluidly coupled to the fitting 402 via a second tubing 206b defining a first test flowpath 310a therein. The system may also include a second closed system 204b fluidly coupled to the fitting 402 via a third tubing 206c defining a second flowpath 310b therein.

[0056] The fitting 402 may include a first opening 312a (to permit the gas flowpath 212 to couple with the flowpath within the fitting 402), a second opening 312b (to permit the first test flowpath 310a to couple with the flowpath within the fitting 402), and a third opening 312c (to permit the second gas flowpath 310b to couple with the flowpath within the fitting 402). The openings, flowpaths, and tubing, as illustrated in FIG. 4B may operate in the same manner as described in FIG. 3B above.

[0057] Additionally, to reiterate from FIG. 4A above, the filter may be integral to the fitting 402, meaning that it is located entirely within the flowpath of the fitting 402, and not within the gas flowpath 212, or either of the first test flowpath 310a or the second test flowpath 310b.

[0058] FIG. 5A illustrates a diagrammatic view of a system including a fitting 502 having an integral filter 304, according to some embodiments. The gas line 40, integrity test instrument 202, first closed system 204a, second closed system 204b, tubing 206, securing clamps 210, filter 304, pinch clamps 306, and aseptic connection 308 as shown in FIG. 4A may operate in the same manner as described above with respect to FIG. 3A.

[0059] The fitting 502 may be a three-way stopcock with an embedded filter 304. A three-way stopcock may be a multi-way valve allowing for independent selection of flowpaths. In other words, the flowpath from the integrity test instrument 202 to the fitting 502, the flowpath from the first closed system 204a to the fitting 502, and the flowpath from the second closed system 204b to the fitting 502 may each be selected independently and completely shut off from the other flowpaths.

[0060] This configuration may include the benefit of enabling the connected systems to maintain positive pressure to the atmosphere, and / or preventing process solutions from coming into contact with the embedded filter 304. Additionally, this configuration may enable independent integrity testing of the first closed system 204a, independent integrity testing of the second closed system 204b, integrity testing of both the first closed system 204a and the second closed system 204b simultaneously, as well as closing off of the integrity test instrument 202 from the system as a whole when it is not in use while maintaining the flowpath between the first closed system 204a and the second closed system 204b.

[0061] FIG. 5B illustrates a diagrammatic view of the system of FIG. 5 A, stated in additional or alternate terms. As shown in FIG. 5B, the system may include an integrity test instrument 202 fluidly coupled to a fitting 502 via a first tubing 206a defining a gas flowpath 212 therein. The system may further include a first closed system 204a fluidly coupled to the fitting 502 via a second tubing 206b defining a first test flowpath 310a therein. The system may also include a second closed system 204b fluidly coupled to the fitting 502 via a third tubing 206c defining a second flowpath 310b therein.

[0062] The fitting 502 may include a first opening 312a (to permit the gas flowpath 212 to couple with the flowpath within the fitting 502), a second opening 312b (to permit the first test flowpath310a to couple with the flowpath within the fitting 502), and a third opening 312c (to permit the second gas flowpath 310b to couple with the flowpath within the fitting 502). The openings, flowpaths and tubing as illustrated in FIG. 5B may operate in the same manner as described in FIG. 3B above.

[0063] Additionally, to reiterate from FIG. 5A above, the filter may be integral to the fitting 502, meaning that it is located entirely within the flowpath of the fitting 502, and not within the gas flowpath 212, or either of the first test flowpath 310a or the second test flowpath 310b.

[0064] FIG. 6 illustrates a diagrammatic view of an integrity testing machine 600, according to some embodiments. The machine 600 may be representative of the integrity test instrument 30 and / or the integrity test instrument 202. The machine 600 may be coupled to a system (e.g., the upper system 10, the lower system 20, the closed system 204, the first closed system 204a, and / or the second closed system 204b) for the purposes of testing the integrity of that system. The machine 600 may be coupled to a gas source 602, such as bottled gas under compression, or a gas utility supply.

[0065] The machine may include and / or house a gas regulator 604 and its associated filters, a gas manifold 606, an integrity test regulator 608 and its associated filters, a gas supply valve 610, a pressure sensor 612, and a flow meter 614, in line with and along the flowpath of the gas source 602. An integrity test tube 616 is also in line with and along this flowpath, and may permit the system to be tested to be coupled to this flowpath. For example, the integrity test tube 616 may include gas line 40 as described herein.

[0066] Each of the gas manifold 606, the integrity test regulator 608, the gas supply valve 610, the pressure sensor 612, and the flow meter 614, may be electrically and / or communicatively coupled to a computer 618, which also may be integral to the machine 600. The computer 618 may automatically perform integrity tests on systems connected to the integrity test tube 616, and / or be operable by a user.

[0067] Integrity testing may be performed by opening the gas supply valve 610, thereby opening the flowpath between the gas source 602 and the integrity test tube (and thereby any connected system), and monitoring the pressure via the pressure sensor 612. During initial pressurization, the pressure sensor 612 may read lower than the gas regulator 604 setpoint. Once the system has achieved the regulator setpoint, the gas supply may be maintained for a predetermined period of time in order to enable the materials, which may have minor changes due to inherent elasticity andtemperature change in the gas due to expansion, to equilibrate. After a period of time, the gas supply valve 610 may be closed, and pressure may be monitored via the pressure sensor 612 for decay. A decay in pressure may be indicative of a leak and would require obtaining a new system assembly.

[0068] Additionally or alternatively, the gas in the gas source 602 may be helium, or some other gas capable of being detected using an external instrument.

[0069] In embodiments monitoring pressure decay, the pressure sensor 612 downstream of the gas supply valve 610 measures the pressure supplied. After a stabilizing period, the gas supply valve 610 may close, trapping pressure within the flowpath between the gas supply valve 610 and any system connected via the integrity test tube 616. The pressure sensor 612 may then measure the pressure decay for a period of time, and, using predetermined parameters for acceptable levels of pressure decay, may determine whether the integrity test passes or fails.

[0070] In embodiments using a helium (or other gas) sniffer, the gas provided by the gas source 602 may enter and be contained in the flowpath via the use of the gas supply valve 610 as described above. A helium (or other gas) sniffing instrument may be used to measure the area surrounding an associated aseptic connection along the flowpath between the integrity test tube 616 and the connected system, and if no detection occurs, it may be determined that the seal (e.g., of the system) is integral.

[0071] In embodiments using a bubble, the gas provided by the gas source 602 may enter and be contained in the flowpath via the use of the gas supply valve 610 as described above. A soapy solution may then be applied to the containment mechanism of the flowpath, such as tubing. A lack of bubble formation may indicate that the seal is integral. Additionally or alternatively, the containment mechanism of the flowpath, such as tubing, may be held under water. A lack of bubble formation may indicate that the seal is integral.

[0072] FIG. 7 illustrates a flowchart depicting the overview of the process of integrity testing a flowpath of a system, according to some embodiments. In some embodiments, the method includes the system displaying “Ready to begin integrity test?” (at step 700). This step may be to convey to a user that integrity testing is going to be performed or to give the user an option to bypass this testing. According to some embodiments, the user confirms that they and the system are ready to begin the integrity test (at step 702).

[0073] The filling system may then perform the integrity test (at step 704). This initial integrity test may be for the flowpath coming from a reservoir. The integrity test is detailed further in FIGS. 9-11 below. After this step, the method continues with the overview process as described in FIG. 8 below.

[0074] FIG. 8 illustrates a continuation of the flowchart depicting the overview of the process of integrity testing the flowpath of the system, according to some embodiments. In some embodiments, the method includes the system displaying “Integrity test passed. Clamp inlet port and connect product.” (at step 800). This may convey to the user that the system has passed the integrity test for the inlet port and instruct them to prepare the flowpath to the containers. According to some embodiments, the user confirms this message (at step 802).

[0075] The system may then perform an additional integrity test (at step 804). This integrity test may be for the flowpath going toward the containers to be filled. This integrity test may be the same integrity test as that mentioned in step 704 above, and as such, this integrity test is detailed further in FIGS. 9-11 below.

[0076] FIG. 9 illustrates a flowchart depicting a method of testing the integrity of the filling system, according to some embodiments. When the filling system performs the integrity test (at steps 704 and / or 804), the system or operator may set the integrity test valve to supply (at step 900). At this point, the operator may choose to perform helium testing (at step 902) and / or pressure decay testing (at step 904). The filling system may also automatically perform either the helium testing (at step 902) or the pressure decay testing (at step 904). The helium testing is detailed further below in FIG. 10. The pressure decay testing is detailed further below in FIG. 11.

[0077] If the operator or filling system does not need to perform either the helium testing or the pressure decay testing, the method may move to ensuring that all positions have been tested and passed (at step 906). Similarly, once the helium testing and / or pressure testing has been successfully passed, the method may move to ensuring that all positions have been tested and passed (at step 906).

[0078] If all positions have not been tested or have not passed the test, the method may include adjusting the settings (at step 908) and / or adjusting the parameters of the system being tested. After this, the system may once again perform helium testing (at step 902) and / or pressure decay testing (at step 904).

[0079] If all positions have been tested and passed the test, then the operator or filling system may set the integrity valve to venting (at step 910). In some embodiments, the system is then removed and / or disconnected from the integrity test machine (at step 912).

[0080] The assembly integrity test (coming from step 704 in FIG. 7 above) and the sterile connection integrity test (coming from step 804 in FIG. 8 above) may be the same sequence of steps but with different parameters for timeout and maximum pressure decay.

[0081] FIG. 10 illustrates a flowchart depicting a method of performing helium testing, according to some embodiments. In some embodiments, the method includes pressurizing the filling system to a setpoint (at step 1000). According to some embodiments, the setpoint is reached (at step 1002), and the pressure is held for a predetermined specified hold time (at step 1004). The filling system may then begin a helium sniffing test, confirming when the test has been completed (at step 1006). If the helium sniffing test does not return with a high or outside of nominal value (at step 1008), the method returns to confirming that all positions have been tested and passed (at step 906 of FIG. 9 above).

[0082] If the helium sniffing test does return with a high or outside of nominal value (at step 1008), the user is prompted to either abort the filling of the containers, as a breach has been found and contamination of the recipe may have occurred, or retry the helium sniffing test (at step 1014). If the user chooses to abort the filling of the containers, the procedure stops entirely (at step 1016). If the user chooses to retry the helium sniffing test, the method returns to attempting to pressurize the filling system to a setpoint.

[0083] If, while the filling system is attempting to pressurize to a setpoint (at step 1000), and it fails to do so before a timeout timer is reached (at step 1010), the filling system indicates to the user that such a timeout time has been reached and indicates to the user to check the connections between components of the filling system (at step 1012).

[0084] Once the user receives this notification, they may be prompted to either abort the filling of the containers, as a breach has been found and contamination of the recipe may have occurred, or retry pressurizing the filling system to a setpoint (at step 1014). If the user chooses to abort the filling of the containers, the procedure stops entirely (at step 1016). If the user chooses to retry pressurizing the filling system to a setpoint, the method returns to the start point at step 1000.

[0085] FIG. 11 illustrates a flowchart depicting a method of performing pressure decay testing, according to some embodiments. In some embodiments, the method includes pressurizing thefilling system to a setpoint (at step 1100). According to some embodiments, the setpoint is reached (at step 1102), and the pressure is held for a predetermined specified hold time (at step 1104). The filling system may then begin a pressure decay test (at step 1106). If the pressure decay value is not exceeded (at step 1108), the method returns to confirming that all positions have been tested and passed (at step 906 of FIG. 9 above).

[0086] If the pressure decay value is exceeded (at step 1108), the user is prompted to either abort the filling of the containers, as a breach has been found and contamination of the recipe may have occurred, or retry the pressure decay test (at step 1114). If the user chooses to abort the filling of the containers, the procedure stops entirely (at step 1116). If the user chooses to retry the helium sniffing test, the method returns to attempting to pressurize the filling system to a setpoint.

[0087] If, while the filling system is attempting to pressurize to a setpoint (at step 1100), and it fails to do so before a timeout timer is reached (at step 1110), the filling system indicates to the user that such a timeout time has been reached and indicates to the user to check the connections between components of the filling system (at step 1112).

[0088] Once the user receives this notification, they may be prompted to either abort the filling of the containers, as a breach has been found and contamination of the recipe may have occurred, or retry pressurizing the filling system to a setpoint (at step 1114). If the user chooses to abort the filling of the containers, the procedure stops entirely (at step 1116). If the user chooses to retry pressurizing the filling system to a setpoint, the method returns to the start point at step 1100.

[0089] EMBODIMENT 1

[0090] Some embodiments of the present disclosure include a device. In some embodiments the device includes a fitting including a first opening, a second opening, and a flowpath therebetween. According to some embodiments, the device includes a filter disposed within the flowpath, the filter configured to remove impurities from a fluid.

[0091] EMBODIMENT 2

[0092] Some embodiments of the present disclosure include the device of EMBODIMENT 1, wherein the filter includes i) a single-layer hydrophobic filter, ii) a hydrophobic large pore fabric, iii) a positively charged filter material, iv) a negatively charged filter material, v) a multi-charged filter, vi) a sterilizing grade filter, or vii) combinations thereof.

[0093] EMBODIMENT 3

[0094] Some embodiments of the present disclosure include the device of EMBODIMENT 1 or 2, wherein the filter is completely contained within the fitting.

[0095] EMBODIMENT 4

[0096] Some embodiments of the present disclosure include the device of any of EMBODIMENTS 1-3, wherein the filter includes a maximum dimension from about 0.5 millimeters (mm) and about 500 millimeters (mm).

[0097] EMBODIMENT 5

[0098] Some embodiments of the present disclosure include the device of any of EMBODIMENTS 1-4, wherein the filter includes a maximum thickness from about 0.5 mm and about 100 mm.

[0099] EMBODIMENT 6

[0100] Some embodiments of the present disclosure include the device of any of EMBODIMENTS 1-5, wherein the fitting includes i) a threaded fitting, ii) a hose barb, iii) a luer, iv) a sanitary connection, v) a quick connect, vi) or combinations thereof, and wherein the filter is embedded within the fitting.

[0101] EMBODIMENT 7

[0102] Some embodiments of the present disclosure include the device of any of EMBODIMENTS 1-6, wherein the device further includes a valve disposed within the flowpath, the valve configured to regulate a flow of the fluid therethrough.

[0103] EMBODIMENT 8

[0104] Some embodiments of the present disclosure include the device of EMBODIMENT 7, wherein the valve includes a stopcock.

[0105] EMBODIMENT 9

[0106] Some embodiments of the present disclosure include the device of EMBODIMENT 8, wherein the valve includes a three-way stopcock.

[0107] EMBODIMENT 10

[0108] Some embodiments of the present disclosure include the device of any of EMBODIMENTS 1-9, wherein the fitting is a T-fitting.

[0109] EMBODIMENT 11

[0110] Some embodiments of the present disclosure include the device of any of EMBODIMENTS 1-10, wherein the fitting includes a maximum inner dimension from about 0.1 mm and about 100 mm.

[0111] EMBODIMENT 12

[0112] Some embodiments of the present disclosure include the device of any of EMBODIMENTS 1-11, wherein the fluid includes a gas.

[0113] EMBODIMENT 13

[0114] Some embodiments of the present disclosure include a system including a device of any of EMBODIMENTS 1-12. In some embodiments, the system includes an integrity test instrument fluidly coupled with the device.

[0115] EMBODIMENT 14

[0116] Some embodiments of the present disclosure include the system of EMBODIMENT 13, wherein the integrity test instrument includes a tubing that fluidly couples the integrity test instrument to the device.

[0117] EMBODIMENT 15

[0118] Some embodiments of the present disclosure include the system of EMBODIMENT 14, wherein the tubing defines a gas flowpath.

[0119] EMBODIMENT 16

[0120] Some embodiments of the present disclosure include the system of EMBODIMENT 14 or 15, wherein the tubing fluidly couples the integrity test instrument to the first opening of the fitting.

[0121] EMBODIMENT 17

[0122] Some embodiments of the present disclosure include the system of any of EMBODIMENTS 13-16, wherein the integrity test instrument includes i) a gas regulator, ii) a gas manifold, iii) an integrity test regulator, iv) a gas supply valve, v) a pressure sensor, vi) a flow meter, vii) a computer, or viii) combinations thereof.

[0123] EMBODIMENT 18

[0124] Some embodiments of the present disclosure include the system of any of EMBODIMENTS 14-17, the system further including a securing clamp configured to secure the tubing to the fitting.

[0125] EMBODIMENT 19

[0126] Some embodiments of the present disclosure include the system of any of EMBODIMENTS 13-18, wherein the device is configured to fluidly couple to an closed system.

[0127] EMBODIMENT 20

[0128] Some embodiments of the present disclosure include the system of EMBODIMENT 19, wherein the tubing is a first tubing, and wherein the device is configured to couple to the closed system via a second tubing.

[0129] EMBODIMENT 21

[0130] Some embodiments of the present disclosure include the system of EMBODIMENT 20, wherein the second tubing defines a test flowpath.

[0131] EMBODIMENT 22

[0132] Some embodiments of the present disclosure include the system of EMBODIMENT 20 or 21, wherein the second tubing is configured to fluidly couple the closed system to the device via the second opening.

[0133] EMBODIMENT 23

[0134] Some embodiments of the present disclosure include the system of any of EMBODIMENTS 20-22, wherein the securing clamp is a first securing clamp, the system further including a second securing clamp configured to secure the second tubing to the fitting.

[0135] EMBODIMENT 24

[0136] Some embodiments of the present disclosure include the system of any of EMBODIMENTS 20-23, the system further including a pinch clamp located about the second tubing and configured to i) open, ii) restrict, iii) block, or iv) or any combination thereof the test flowpath.

[0137] EMBODIMENT 25

[0138] Some embodiments of the present disclosure include the system of any of EMBODIMENTS 19-24, wherein the closed system is a first closed system, and wherein the device is further configured to fluidly couple to a second closed system.

[0139] EMBODIMENT 26

[0140] Some embodiments of the present disclosure include the system of EMBODIMENT 25, wherein the device is configured to fluidly couple to the second closed system via a third tubing.

[0141] EMBODIMENT 27

[0142] Some embodiments of the present disclosure include the system of EMBODIMENT 26, wherein the test flowpath is a first test flowpath, and wherein the third tubing defines a second test flowpath.

[0143] EMBODIMENT 28

[0144] Some embodiments of the present disclosure include the system of EMBODIMENT 26 or 27, wherein the device includes a third opening, and wherein the third tubing is configured to fluidly couple the second closed system to the device via the third opening.

[0145] EMBODIMENT 29

[0146] Some embodiments of the present disclosure include the system of any of EMBODIMENTS 26-28, the system further including a third securing clamp configured to secure the third tubing to the fitting.

[0147] EMBODIMENT 30

[0148] Some embodiments of the present disclosure include the system of any of EMBODIMENTS 26-29, wherein the pinch clamp is a first pinch clamp, the system further including a second pinch clamp located about the third tubing and configured to i) open, ii) restrict, iii) block, or iv) or any combination thereof the second test flowpath.

[0149] EMBODIMENT S !

[0150] Some embodiments of the present disclosure include the system of any of EMBODIMENTS 19-30, wherein the filter is configured to maintain a sterility of i) the first closed system, ii) the second closed system, iii) the flowpath, iv) the first test flowpath, v) the second test flowpath, or vi) combinations thereof.

[0151] Some of the components listed herein use the same number from figure to figure. It should be appreciated these components use the same numbers solely for ease of reference and to facilitate comprehension for the reader. While these components may use the same numbers, differences may be present in these components as illustrated in the various figures in which they appear and as described in the specification herein.

[0152] None of the steps described herein is essential or indispensable. Any of the steps can be adjusted or modified. Other or additional steps can be used. Any portion of any of the steps, processes, structures, and / or devices disclosed or illustrated in one embodiment, flowchart, or example in this specification can be combined or used with or instead of any other portion of anyof the steps, processes, structures, and / or devices disclosed or illustrated in a different embodiment, flowchart, or example. The embodiments and examples provided herein are not intended to be discrete and separate from each other.

[0153] The section headings and subheadings provided herein are nonlimiting. The section headings and subheadings do not represent or limit the full scope of the embodiments described in the sections to which the headings and subheadings pertain. For example, a section titled “Topic 1” may include embodiments that do not pertain to Topic 1 and embodiments described in other sections may apply to and be combined with embodiments described within the “Topic 1” section.

[0154] The various features and processes described above may be used independently of one another, or may be combined in various ways. All possible combinations and subcombinations are intended to fall within the scope of this disclosure. In addition, certain method, event, state, or process blocks may be omitted in some implementations. The methods, steps, and processes described herein are also not limited to any particular sequence, and the blocks, steps, or states relating thereto can be performed in other sequences that are appropriate. For example, described tasks or events may be performed in an order other than the order specifically disclosed. Multiple steps may be combined in a single block or state. The example tasks or events may be performed in serial, in parallel, or in some other manner. Tasks or events may be added to or removed from the disclosed example embodiments. The example systems and components described herein may be configured differently than described. For example, elements may be added to, removed from, or rearranged compared to the disclosed example embodiments.

[0155] Conditional language used herein, such as, among others, "can," "could," "might," "may," “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements and / or steps. Thus, such conditional language is not generally intended to imply that features, elements and / or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and / or steps are included or are to be performed in any particular embodiment. The terms “comprising,” “including,” “having,” and the like are synonymous and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, forexample, to connect a list of elements, the term “or” means one, some, or all of the elements in the list. Conjunctive language such as the phrase “at least one of X, Y, and Z,” unless specifically stated otherwise, is otherwise understood with the context as used in general to convey that an item, term, etc. may be either X, Y, or Z. Thus, such conjunctive language is not generally intended to imply that certain embodiments require at least one of X, at least one of Y, and at least one of Z to each be present.

[0156] The term “and / or” means that “and” applies to some embodiments and “or” applies to some embodiments. Thus, A, B, and / or C can be replaced with A, B, and C written in one sentence and A, B, or C written in another sentence. A, B, and / or C means that some embodiments can include A and B, some embodiments can include A and C, some embodiments can include B and C, some embodiments can only include A, some embodiments can include only B, some embodiments can include only C, and some embodiments can include A, B, and C. The term “and / or” is used to avoid unnecessary redundancy.

[0157] While certain example embodiments have been described, these embodiments have been presented by way of example only, and are not intended to limit the scope of the inventions disclosed herein. Thus, nothing in the foregoing description is intended to imply that any particular feature, characteristic, step, module, or block is necessary or indispensable. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms; furthermore, various omissions, substitutions, and changes in the form of the methods and systems described herein may be made without departing from the spirit of the inventions disclosed herein.

Claims

CLAIMSWe Claim:

1. A device, comprising: a fitting comprising a first opening, a second opening, and a flowpath therebetween; and a filter disposed within the flowpath, the filter configured to remove impurities from a fluid.

2. The device of Claim 1, wherein the filter comprises i) a single-layer hydrophobic filter, ii) a hydrophobic large pore fabric, iii) a positively charged filter material, iv) a negatively charged filter material, v) a multi-charged filter, vi) a sterilizing grade filter, or vii) combinations thereof.

3. The device of Claim 1, wherein the filter is completely contained within the fitting.

4. The device of Claim 1, wherein the filter comprises a maximum dimension from about 0.5 millimeters (mm) and about 500 millimeters (mm).

5. The device of Claim 1, wherein the filter comprises a maximum thickness from about 0.5 mm and about 100 mm.

6. The device of Claim 1, wherein the fitting comprises i) a threaded fitting, ii) a hose barb, iii) a luer, iv) a sanitary connection, v) a quick connect, vi) or combinations thereof, and wherein the filter is embedded within the fitting.

7. The device of Claim 1, further comprising a valve disposed within the flowpath, the valve configured to regulate a flow of the fluid therethrough.

8. The device of Claim 7, wherein the valve comprises a stopcock.

9. The device of Claim 7, wherein the valve comprises a three-way stopcock.

10. The device of Claim 1, wherein the fitting is a T-fitting.

11. The device of Claim 1, wherein the fitting comprises a maximum inner dimension from about 0.1 mm and about 100 mm.

12. The device of Claim 1, wherein the fluid comprises a gas.

13. A system, comprising: a device, comprising: a fitting comprising a first opening, a second opening, and a flowpath therebetween, and a filter disposed within the flowpath, the filter configured to remove impurities from a fluid; and an integrity test instrument fluidly coupled with the device.

14. The system of Claim 13, wherein the integrity test instrument comprises a tubing that fluidly couples the integrity test instrument to the device.

15. The system of Claim 14, wherein the tubing defines a gas flowpath.

16. The system of Claim 14 , wherein the tubing fluidly couples the integrity test instrument to the first opening of the fitting.

17. The system of Claim 13, wherein the integrity test instrument comprises i) a gas regulator, ii) a gas manifold, iii) an integrity test regulator, iv) a gas supply valve, v) a pressure sensor, vi) a flow meter, vii) a computer, or viii) combinations thereof.

18. The system of Claim 14, further comprising a securing clamp configured to secure the tubing to the fitting.

19. The system of Claim 18, wherein the device is configured to fluidly couple to a closed system.

20. The system of Claim 19, wherein the tubing is a first tubing, and wherein the device is configured to couple to the closed system via a second tubing.

21. The system of Claim 20, wherein the second tubing defines a test flowpath.

22. The system of Claim 20, wherein the second tubing is configured to fluidly couple the closed system to the device via the second opening.

23. The system of Claim 20, wherein the securing clamp is a first securing clamp, the system further comprising a second securing clamp configured to secure the second tubing to the fitting.

24. The system of Claim 21 , further comprising a pinch clamp located about the second tubing and configured to i) open, ii) restrict, iii) block, or iv) or any combination thereof the test flowpath.

25. The system of Claim 19, wherein the device is further configured to fluidly couple to a second closed system.

26. The system of Claim 25, wherein the device is configured to fluidly couple to the second closed system via a third tubing.

27. The system of Claim 26, wherein the test flowpath is a first test flowpath, and wherein the third tubing defines a second test flowpath.

28. The system of Claim 26, wherein the device comprises a third opening, and wherein the third tubing is configured to fluidly couple the second closed system to the device via the third opening.

29. The system of Claim 26, further comprising a third securing clamp configured to secure the third tubing to the fitting.

30. The system of Claim 26, further comprising a second pinch clamp located about the third tubing and configured to i) open, ii) restrict, iii) block, or iv) or any combination thereof the second test flowpath.

31. The system of Claim 25, wherein the filter is configured to maintain a sterility of i) a first closed system, ii) the second closed system, iii) the flowpath, iv) the first test flowpath, v) the second test flowpath, or vi) combinations thereof.

Images